Background

One of the most critical roles in clinical studies is monitoring. Monitoring to ensure that the data is collected according to the protocol and standard operating procedures; the data is correct, accurate and clean according to good clinical practices and are well documented and verifiable; and subjects are kept safe in the process. This normally requires the monitor to visit the study site frequently to monitor the data collection and review the data that has been collected. Additionally, the monitor ensures that all medications being studied are kept under appropriate environmental conditions. Generally, after conducting initial site visits, monitors visit sites about every 2 months in order to review source documents and ensure data integrity.

Monitoring site visits are generally lengthy and arduous as lots of time is spent reviewing and comparing source documents to the data that is collected for the study to ensure it is correct. The most common findings during site monitoring are: failure to follow the protocol, failure to keep adequate and accurate records, a problem with the informed consent, failure to report adverse events, and failure to dispose of study drugs adequately.

By the time the monitor identifies that a participating site has either failed to follow the protocol or failed to keep adequate and accurate records, several cases may be lost. This is not only expensive, but also delays the study. As an industry, the number of subjects required for any given study is based on the ability to obtain a power of 80. Being able to collect better data and adhere to the protocol would increase the power and decrease the number of subjects needed to achieve that power.

Challenge

The challenge was to enable monitors to have access to real-time data. This would allow monitoring to occur very quickly after the data was entered.  Timely monitoring would quickly identify any protocol deviations, allow the clarification of any questionable data, and would allow quick response to adverse events.

Monitors log into VISION every morning and look at what happened yesterday.

Johny said they spend 30 min each day on this. ID problems. Then charges and spends time on corrective action.

At any point, they have realtime knowledge of what is happening within their projects. On paper they would handle 1-2 studies. On VISION, they can handle 5-6 studies.

Loses $ on the site visits, but he gains because he is charging more on an hr rate. For corrective actions.

Reduced cost of N.

Enables monitors to have visibility into study data in real-time.

A DATABASE is just random data. VISION allows us to turn data into knowledge and allows us to better monitor the study and immediately work on corrective actions which in turn drives compliance.  95% of the data entered into VISION is not modified. – Queries/field and through history of fields. Monitoring is reduced to 5% of data that is needing corrective action.  Cleaner data fast.

Reduces fraud.

Metrics out of VISION –

Want to get 95% of data entered once. How can we measure this?

Less data lost. u/k data.

Fewer deviations.  Deviations/subject

Completing their studies sooner.

Lowers cost.

Estimated amount of data being unevaluable (Study power). Impact study power. 80% power versus 85% in real $ is $800K – 1M in cost on the human side. (from literature)

Using VISION can help them to require fewer patients because that data is that much better. The impact is that it touches everything.

Caryn Thompson – can VISION save you on power.

Metric – cost/time savings with using the interface Inventory and shipment management interface – 3K.

Proposal

Prelude Dynamics proposed utilization of VISION™, an electronic data collection system, to allow researchers to capture information in real-time, provide the standardized scales in a just-in-time manner, follow the natural work flow of the study process, and ease the data collection process. In order to restrict the scales to the appropriate individuals, form level permissions would be assigned to specific roles. VISION™ would be programmed to use custom calculations to automatically start the clock from the surgical start time entered and provide the correct dosing amount of any medications administered.

Background

It is a common study objective to understand how animals respond to a certain surgical procedure, anesthesia, or post-surgery medications. Researchers examine an animal’s response at specific time intervals over a period of time to reach this understanding. When this time period extends over multiple days, it is necessary to utilize multiple observers to complete standardized scales.

When the data is collected on paper, it is difficult to blind current observers from information completed on forms by a previous observer. Access to previously entered information can bias the current observer, regardless of whether he or she collected the prior observation or it was collected by someone else. Reducing bias is important to obtaining reliable information.

Solution

Prelude staff trained the study staff to utilize VISION™ to show and provide access to only one scale at a time, restricting access to the individual with the appropriate permission at the designated time. VISION™ was programmed to start running the time clock off the entered surgical start time. Permissions were assigned to roles that corresponded with access to particular scale forms as indicated in the study protocol. Some scales could only be filled out by a certain role while others had multiple roles that could fill them out. Once a scale was filled in and signed off on, that scale became inaccessible or hidden and the next scale became accessible. Based on the initial entered surgical start time, each scale displayed the expected date and time that scale needed to be filled in.

As a standard, VISION collects full audit trail information on each data point entered into the system, including who entered the information and a date and time stamp. It also allows data entry fields to be augmented with comments or notes, which is an important feature if additional information needs to be added that might otherwise be limited to a selection of choices.

VISION™ also contains pre-existing summaries which assist in monitoring the data being collected at the patient level, at each site or for the study as a whole. Using VISION™’s search and filter capacity allows these summaries to display data of only the cases fitting the search criteria. Additionally, VISION™ provides users with certain permissions the ability to create ad-hoc reports which they can use for monitoring additional criteria or in order to answer important research questions. The data within the system is available for export 24/7/365 with the appropriate user permission. Export features the ability to export in multiple formats including SAS-ready format.

Results & Benefits

Real-time data is being entered into VISION™, and standardized scales are being filled in and signed off on, the completed form is no longer accessible to the individuals completing forms.  Using VISION™ eliminates observer bias since current observers cannot view or compare findings entered by a prior observer. There are certain roles designated by the Sponsor to maintain read-only access to view all the scales at any time.

Additionally, scale scores are immediately calculated and feedback automatically provided if scores indicate necessity for removal from the study or other treatment. This identifies potential problems quickly and reduces the risk to the participating animal.

VISION™ also identifies these animals quickly so they can be taken out of the study and prevent further costs associated with tracking an ineligible subject. Additionally, when an animal is removed from the study, VISION™’s Randomization module which is behind the scenes, and will reassign the withdrawn animal’s treatment to a new case to ensure that sufficient cases are enrolled for each treatment group.

The need for data collection on paper CRF has been eliminated. Researchers spend less time entering data after the fact because they are able to enter information directly into the system in real-time. There is also a cost savings and error reduction by eliminating data entry at a later date.

Additionally, the data is accessible in real time for query, review, analysis and export. Users report the streamlining of the process has helped reduce errors and improved efficiency.

About Prelude Dynamics & VISION™

Prelude Dynamics is a global provider of customized web-based software systems for data collection, analysis and management of clinical trials, studies and registries. We streamline eClinical operations through our unique and innovative VISION software system, which allows us to rapidly configure data collection solutions for pharmaceutical, CRO, medical device, animal health, and university organizations.

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